Good day ladies and gentlemen and welcome to the NPS Pharmaceuticals Conference Call. My name is Gary and I will be your operator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of the conference. (Operator Instructions) As a reminder this call is being recorded for replay purposes. I would now like to turn the call over to Susan Mesco. Over to you.

Susan Mesco

Thank you, Gary. Welcome to today’s conference call to discuss NPS’s acquisition of the worldwide rights to teduglutide and PTH 1-84. Joining me on today’s call are Dr. Francois Nader, our President and Chief Executive Officer and other members of our members of our executive management team.

Before we start, let me remind you that today’s call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties. Please refer to our filings with the SEC, which are available from the SEC or our website for information concerning the risk factors that could affect the company.

Today, Dr. Francois Nader will provide an overview on the transaction; Eric Pauwels will also provide you with a brief update on the US launch of Gattex. After our remarks, we will open up the call for Q&A.

I will now turn the call over to Dr. Nader.

Francois Nader

Thank you, Susan and good morning. Thank you everyone for joining us today. In the recent past, NPS underwent key transformative events starting with the turnaround of the company that began in early 2007 with our decision to focus on rare diseases and reprioritize our pipeline on orphan indication.

Through the successful execution of our strategy, we completed the clinical development of two orphan products, teduglutide and PTH 1-84 and secured marketing approvals in the US for Gattex and in Europe for Revestive.

Today, I am thrilled to announce yet another transforming event for NPS, the emergence of our company as a global commercial rare disease company through the acquisition of ex US rights to teduglutide and PTH from Takeda.

We believe that breakthrough products like teduglutide and PTH, along with ownership of worldwide rights and targeted international operations are key elements to commercial success and value creation. This has been proven by companies like Alexion, Biomarin, Genzyme, just to name a few.

Establishing an international presence was a key initiative that was identified as part of our long-term strategic plan. In our discussions with Takeda and as stated by Frank Morich, Takeda’s Chief Commercial Officer in his quote, it became increasingly evident that NPS was best suited to maximize the global value of teduglutide and PTH.

We know these products inside out whether the clinical data, the target prescribers or the patients’ needs. And with the US launch of Gattex, we have developed a successful, patient-centric commercial strategy that now can be leveraged elsewhere in the world. With that transaction, NPS now has a portfolio of products approved and marketed in the US and in Europe.

Consolidating the worldwide rights will enable us to develop and execute an integrated global commercial and line extension strategy for teduglutide and for PTH. Financially, the terms of this transaction are also very favorable to NPS. Takeda will receive NPS common stock valued at $50 million. This structure allows us to preserve cash with only approximately a 7% impact to NPS shares outstanding.

Importantly though, the equity-based nature of the transaction underscores Takeda’s belief in the potential of these products and enables them to participate in NPS’s commercial success. In return, NPS will receive worldwide rights for two commercial products, significant API inventory for both products, the cutting-edge manufacturing process for teduglutide and a new pen device for PTH.

Takeda will be eligible to receive a one-time $30 million milestones payment in the first calendar year that combined worldwide net sales of both products exceed $750 million. NPS has the option of making this milestone payment in cash or NPS common stock.

So where do we go from here. While we have internal expertise in global development and commercialization, I have asked our US-based team to continue focusing on the launch of Gattex and the filing of Natpara in the US.

To oversee the design and execution of NPS global strategy, it is my pleasure to announce that we have retained the consulting services of Sandy Smith, who as many of you may know, served as Executive Vice President and President of Genzyme’s international group.

Under Sandy’s leadership, Genzyme’s international revenue grew to 65% of Genzyme’s nearly $5 billion in revenues. He was also responsible for Genzyme’s successful global launch of twelve new products. Sandy will work directly with me to lay the foundation of NPS international expansion and position PTH and teduglutide for global commercial success.

Over the next few months, we will focus on the following three priorities; first, we will design and implement NPS global corporate structure, we will also define our global business model and initiate the identification of the key opinion leaders of our international organization; and our third priority will be to develop global product strategies that maximize the commercial value of teduglutide and PTH.

Specifically for teduglutide, our strategy will take into consideration current insights into optimal pricing and reimbursement afterwards, along with launch sequencing. As you probably are aware of, in Europe, the orphan status of Revestive will provide ten years of commercial exclusivity through mid-2022.

For PTH, we will assess the future of the osteoporosis indication and the opportunity to file for approvals of Natpara in hypoparathyroidism outside of the US. While we are developing our global strategy, we will immediately implement a number of operational tactics.

First, starting working with Takeda to transfer the data, knowledge and technology related to Revestive and Preotact. We will initiate the pricing and reinvestment profit for Revestive in the European countries and while waiting for Revestive to be reimbursed, we will launch a short bowel syndrome named patient program in certain European countries.

Lastly and to avoid unnecessary duplication, we will integrate the R&D and technical operations activities between the US and Europe as they relate specifically to the teduglutide registry and pediatric program as well as activities related to resolving the PTH manufacturing issue.

Importantly, we do not expect these initiatives to materially impact this year’s expenses and we are reiterating our full year operating expense guidance of $135 million to $145 million.

In fact, the named patient program could generate increased revenues from international sales. While we are really excited with this unique opportunity to propel NPS into a global commercial orphan business we are very cognizant that our first and foremost priorities in 2013 remain the successful launch of Gattex in the US and the filing of the US BLA for Natpara.

Our teams are making good progress on resolving the Natpara manufacturing issue and we are planning to file the BLA in the second half of this year. And I am pleased to report that we have all hands on deck to successfully launch Gattex in the US and the first weeks of the launch, has met, if not exceeded our expectations.

I would like now to give Eric Pauwels, our Chief Commercial Officer the opportunity to provide to more color on the launch of Gattex. Eric?

Eric Pauwels

Thank you, Francois and good morning to everyone joining today’s call. We continue to be enthusiastic about the US launch of Gattex, which is now in week six and progressing according to plan.

When we last spoke at the end of February, we reported that our first short bowel syndrome patients were on Gattex. I am pleased to report that we have continued to add to that base with additional patients initiating therapy over the past few weeks. As you know, the number of patients on the drug is really the best indicator of revenues.

Since the number of patients on Gattex will be meaningful only after a couple of quarters in the launch, we will begin reporting this number to you starting with our second quarter call. Meanwhile, we will provide you with some metrics that help you track our progress.

72 prescriptions have been written so far and are being processed by NPS Advantage where our care coordinators are successfully managing benefits investigations and patient assistance programs to ensure that there is little or no out-of-pocket burden for our patients.

And our field force is actively engaging our target gastroenterologists. Over 160 physicians are now REMS trained. While these are very encouraging early indicators of physician adoption, as a reminder, this is only five weeks of data and we will remain mindful that the early phase of launch can be driven by the most motivated patients and prescribers.

We continue to expect to have between 200 to 300 patients on Gattex by the end of 2013 with the vast majority of these patients initiating therapy in the latter part of the year. We have also continued to be pleased with our patient finding activities as a result of the deployment of area business specialists and our field organization, the success of our educational site shortbowelsupport.com and the ongoing awareness generated by patient advocacy groups.

Regarding peers, I am happy to report that since the launch our key account directors and MSLs has made formal presentations of the Gattex value proposition to 26 health plans representing over 100 million lives. We have been very encouraged by the feedback we have received during these interactions as well as in the meetings we have had with the pharmacy benefit managers.

As a result of these efforts, a wide range of payers, both national, regional, public and private have indicated coverage of Gattex and as expected, many payers are requesting prior authorizations to the Gattex label. But because our label is very broad, the prior authorization does not – be a hurdle for Gattex coverage and reimbursement.

So, in summary, we have worked very hard to get the US Gattex launch off to a strong start and don’t remind early days, we are very pleased with our progress so far. We look forward to updating you on the US launch at the next opportunity.

With that, I will turn the call back to the operator to begin our Q&A session. Operator?

Question-and-Answer-Session

Operator

(Operator Instructions) We have our first question coming from the line of Alan Carr of Needham and Company. Over to you Alan.

Alan Carr – Needham & Co

Hi, thanks for taking my questions. Can you discuss a bit more about where things do stand in terms of negotiating with the countries over there? How much progress have Takeda made? And how much progress they’ve made in terms of characterizing the market over there?

Francois Nader

Good morning, Alan. We are in the process actually of digging into the documents and talking to the Takeda folks in Europe. We are not aware of any formal approach yet in terms of initiating the pricing and the reimbursement process. But stay tuned. As I said, this will be our number one priority and we will initiate these activities as soon as practically possible.

Alan Carr – Needham & Co

Why was this prices not initiated back last year when the drug was approved over there?

Francois Nader

Well, this is a question that I suggest you to address to Takeda, one of the reasons could be that we had to secure the approval in the US first and secure the pricing in the US first, but for more details, I suggest you, you connect with Takeda.

Alan Carr – Needham & Co

And then one last one, you had a monetization arrangement around Preotact. What sort of impact does this have?

Francois Nader

I’ll ask Luke to address this question.

Luke Beshar

Yes, good question. DRI is the counterparty there. They have that monetization as you recall is now recourse to the company. DRI does have – it is secured by the economic value of that molecule to NPS. So, we are – now we got PTH back. We work very closely with DRI to the extent we can optimize the value of that product whatever way we go and then we will work with DRI to work through the economics with them.

Alan Carr – Needham & Co

Okay, and then, last one, what are your plans for osteoporosis over there? Do you have an option – opportunity here to focus on PTH a rare disease with premium pricing over there. Can you tell us a little bit more about what you are thinking there?

Luke Beshar

As I mentioned a minute ago, we will certainly look at the future of the osteoporosis indication. As you might recall, Preotact was withdrawn from the European market because of manufacturing issues back in the summer. So all patients that were on Preotact back then have been transferred to another drug.

So we would be looking at whether or not the osteoporosis indication whether in Europe or elsewhere would make sense. Certainly, our core business is the orphan diseases, orphan indication. We strongly believe that the choice we made in the US in switching the indication from osteoporosis to hypoparathyroidism was the right choice.

As for the rest of the world, this is something that we will be evaluating in the weeks and months ahead. But certainly, we believe that given the nature of the osteoporosis market, being in a niche indication like hypoparathyroidism might make more sense.

Alan Carr – Needham & Co

So, the osteoporosis indication may just be dropped entirely?

Luke Beshar

Stay tuned.

Alan Carr – Needham & Co

Thanks for taking my questions.

Francois Nader

Thank you, Alan.

Operator

Thank you. The next question comes from the line of David Friedman of Morgan Stanley. Over to you David.

David Friedman – Morgan Stanley

Thanks for taking the question. Can you just talk a little bit about the timeframe with which you would start spending in Europe? And whether you have ruled out entirely a partner in Europe or and if you had any discussions, whatever thoughts along that line?

Francois Nader

So let me address your first question first. As I again just said, we are reiterating our guidance in terms of operating expenses for 2013 and at the same time, and in parallel, we are just initiating our international expansion. So it frankly would be to define the global structure, define our business model worldwide and define our product strategies.

All these are not, I would say, we don’t need a lot of money to do that. In parallel, we will initiate the process and immediately start initiating the reinvestment process in Europe which again would require fairly minimal investment and put in place the named patient program which again is successful as we hope it will be could be revenue generating.

And then we are working between the two companies if you will to integrate the activities related to pediatric, related to the registry, so that we don’t duplicate if you will efforts between Europe and the US and in the long run, all this will be probably the optimal way of proceeding. Since we already have these activities, the pediatric and the registry already embedded in our plan here in the US for this year.

I don’t foresee it to be an increase, it’s significant at least increase in our expenses. So all in all, at least in the next few months now and the balance of the year, I would think that we will be okay with the current operating expenses guidance. For 2014, stay tuned, because, indeed we are building an international organization and it’s an investment, long-term investment that we will consider.

David Friedman – Morgan Stanley

Great, thanks. And then, just a quick follow-up is, in terms of Europe, do you have a sense as to how broadly you will look to penetrate Europe? Is this primarily Western Europe or will it be Eastern Europe as well?

Francois Nader

Given the centralized regulatory, if you will approach in Europe, we have now Revestive approved in all the European countries. Now when it comes to pricing and reimbursement, it’s on a country-per-country basis and each country has its own rules and regulations for coverage and the reimbursement and pricing.

Needless to say that, we will hit the biggest and most probably profitable countries first, but also in notion of reference pricing, that is very important in staging if you will the sequence of the different launches. So you will see us probably start with the countries that are bigger in size where we already have a good network of key opinion leaders, but also countries that are favorable when it comes to pricing.

David Friedman – Morgan Stanley

Great, thanks. And then, just one quick last question is, do you have any specific opaque on the manufacturing for Natpara? Have you done any of the root cause test runs and may then anything that you can say along the lines there?

Luke Beshar

David, this is Luke. Work is ongoing. We are, as Francois mentioned in his remarks, we are pleased with the progress to-date. The work is not complete. We have probably a dozen experiments that are ongoing.

We should get read out on those various experiments in the second quarter and by the end of the second quarter or before the end of the second quarter, we should have broader clarity on hopefully the definition of the root cause and we will be able to refine our timetable for filing our BLA at the end of the year. So, work is ongoing. We have not gotten the root cause. We have a lot of activities ongoing and we hope to be able to report good news to you in some time in the latter part of the second quarter.

David Friedman – Morgan Stanley

Great, thanks a lot.

Operator

The next question comes from the line of Salveen Richter of Canaccord Genuity. Over to you Salveen. Salveen your line is open. You might need to unmute your line. Go ahead please.

Andrew Goldsmith – Canaccord Genuity

Hello, can you hear me?

Operator

Yes, go ahead.

Andrew Goldsmith – Canaccord Genuity

Great, thank you. This is Andrew Goldsmith on the line for Salveen. Thank you for taking my question. I was wondering, do you have any named patients identified currently at US?

Francois Nader

We have a few patients that have been identified – initiated by Takeda, a handful of patients and the program has started fairly recently.

Andrew Goldsmith – Canaccord Genuity

Okay, fairly recently. And then can you give any kind of color on this thinking forward to how big sales force do you think you’d need at US?

Francois Nader

Based on the experience of others who went ex US and based on conversations that I had with my team here and with Sandy Smith, the consistent feedback that I am receiving is, ex US in the orphan space, the organization and its field organization is usually very small.

If I look at short bowel syndrome in Europe for example, it is very much driven by key opinion leaders and centers of excellence. We had, had this experience during our global development plan and this is why two-third of our patients in our global development plan came from Europe and it was because the sites were able to attract a number of patients given the, I would say, healthcare structure and medical infrastructure in this country.

So when I look at others that went international, again, it’s a relatively small field organization, it’s relatively small actually, structural organization as well. And this is why we are really excited with the opportunity not only to regain the worldwide right, but actually to be able to become as NPS a global company while realigning on its strong US presence and building the presence ex US.

Andrew Goldsmith – Canaccord Genuity

Okay, great. And then, maybe just a quick follow-up here. Do you foresee that the EU filing for Natpara if you go to hypoparathyroidism would be very similar to the data packets that you filed in the US?

Francois Nader

Based on our experience with Gattex and based on our experience before that with osteoporosis actually, it was practically the same file adjusted or adapted if you will to the European structure, the European dossier, but the data was absolutely identical and it’s indeed we go through the hypoparathyroidism route, in Europe, this is exactly what we will be doing.

Andrew Goldsmith – Canaccord Genuity

Okay, great. And then just….

Francois Nader

Let’s create again another very interesting synergy, because we can use our US dossier which has been based on a global development plan, in Europe, in Japan, elsewhere and it is a very strong, a very comprehensive dossier.

Andrew Goldsmith – Canaccord Genuity

Okay, thanks. And then maybe just a brief last one. Have all the payers you’ve talked to on the Gattex launch in the US, do they all require prior authorization or are you seeing some they don’t’?

Francois Nader

No, that Andrew, we talk to with 26 payers right now not all of them have prior authorization, but no major surprises here. They are clearly putting Gattex, they are saying we will cover Gattex, no major pushback, put it on tier-3, tier-4. Prior authorizations tend to be required according to the label. We have a fairly broad label right now. There is only a few payers that have required some reauthorizations. But it tend to be more administrative hurdle and our NPS care coordinators and our specialty infusion partners who are really on top of that assist more of an administrative piece. So, no surprises to-date.

Andrew Goldsmith – Canaccord Genuity

Okay, great. Thanks for taking my questions.

Operator

And the next question comes from the line of David Nierengarten of Wedbush Securities. Over to you David.

David Nierengarten – Wedbush Securities

Thanks for taking the question. I had a question on the pricing in terms of the named patient basis, I would think that you had some kind of idea of what kind of reimbursement you can get through that process and so I was wondering if it was obviously greater than or less than, if you could put a number on the price relative to the US? Thanks.

Francois Nader

I cannot – David, I cannot get, because the named patient program we have initiated, again as I mentioned, it is a handful of patients and the drug is given free of charge. So this is something that we will be working on as soon as today or tomorrow. And I cannot predict what the price will be yet, stay tuned.

David Nierengarten – Wedbush Securities

Okay. All right, thanks.

Francois Nader

Thank you.

Operator

The next question comes from the line of Jim Molloy. Over to you Jim.

Jim Molloy – Janney Montgomery Scott

Thanks, taking my questions. Just want to get clarity, the $750 million worldwide sales, even though Takeda had in the EU to get this deal back you said, if we get the $750 million in US and EU, you have given them the royalty for the – what came after?

Francois Nader

We have given them milestone, it’s not royalty, it’s a milestone, Jim. So the deal is, when combined worldwide revenue for NPS exceeds $750 million in a given calendar for these two products, we will pay Takeda, $30 million in either stock or cash.

Jim Molloy – Janney Montgomery Scott

Okay, excellent. What’s the timeline at the end of that numbers that are realistic numbers you are looking at worldwide, is that something that’s going to maybe happen in the next 10 years, next year?

Eric Pauwels

We don’t give that kind of long-term guidance. But we were obviously very encouraged that – and we believe that $750 million was achievable at some point in the future. What year does that occurs, obviously it’s a bit premature for us to predict that, we are only giving guidance for 2013. And just to reiterate, circling back, there are no royalties, as Nader mentioned royalties, they will get the $30 million milestone, but there is ongoing royalties to Takeda with respect to these two molecules.

Jim Molloy – Janney Montgomery Scott

And could you talk to the magnitude of expenses to the launch of EU infrastructure? Is it equal to what you’ll spending in the US, twice that, half that?

Eric Pauwels

Yes, I would say, stay tuned. These are early days that Sandy is coming on board. Francois will be working close with the teams and Sandy to work, align and actually develop with the commercial strategy for Europe and then the ultimate build out.

So I would suggest that, we just can’t do the income. So, what like to settle in, we’ll do the check transfer and in the weeks and months to come, I think those building blocks will be defined and then we’ll start to build.

Jim Molloy – Janney Montgomery Scott

Okay, great. And I guess a final question, did I heard it correctly, 72 scripts have been written so far, is that the correct number? Is that, I guess 72 patients around the drug already in the first quarter, 200 to 300 seems conservative given how fast you’ve gotten out of the gate?

Eric Pauwels

Jim, the 72 patients that we’ve actually got prescriptions for referrals or prescriptions that are in NPS Advantage. It doesn’t mean all patients are on drug and we are not guiding to the patients, we are not really guiding to patients on drug until we get to our quarterly call.

What this actually means is that, we have actually referral form and we have the prescription and we are going through benefits investigation and signing co-pay assistance. Remember, we’ve guided that it can take three to four months for that process to take place, it doesn’t mean they’ve gone right on to drug.

Some patients with great insurance with no prior authorizations, no co-pays, those are the ones that we’ve identified was been on drug already. But the majority of them are going to take this period of time, just because of the administrative process and the hurdles that we have to get there.

Jim Molloy – Janney Montgomery Scott

Okay, great. Thank you very much taking the questions.

Operator

Thank you and we have the final question from the line of Ed Arce of MLV & Company. Over to you, Arce.

Ed Arce – MLV & Company

Hi, good morning. Thanks for taking my questions. Lot of moving parts to this. I guess lot of questions have already been answered, but just wanted to be short on the clarity of where we stand now in the transfer. At this point, as of yesterday or so, Takeda had not really done very much in terms of reimbursement or in the infrastructure, are you going to be taking on any infrastructure from Takeda?

Francois Nader

That’s a good question actually and this is something that we will be discussing with Takeda in the days and weeks ahead. The reimbursement and pricing in Europe doesn’t require infrastructure, actually there is really a handful of people who could do that. We will be discussing with Takeda whether or not they have the talent within their organization or the talent is available.

Now that we have taken back Revestive and Preotact. If they have the talent, fine, otherwise, we would find the talent somewhere else. Again, we have the network. We know people who can do the work. We are talking about a handful of people. It’s not a lot, but however this, as you can imagine is extremely important, because it is a prerequisite for us to launch Revestive in the European countries. So, and again, too soon to say, but definitely a handful of people that will manage this reimbursement process over the next weeks and months.

Ed Arce – MLV & Company

Okay. And in terms of the cost expense of this change in structure, in addition to that small group of folks in EU, although it’s small, the expense, what other costs would be taken on by NPS?

Francois Nader

At this stage, as I said, we will be really spending the next many months now organizing ourselves, building our strategy for the product, building our corporate structure in terms of designing it and frankly designing our operations out there. I don’t foresee that these activities will be terribly expensive or will generate lot of expenses if you will.

At the same time, we are, as I said, integrating some of the R&D and technical activities. So hopefully this will be done quickly. We don’t want to duplicate between activities done in Europe and in the US specifically related to pediatric and the registry. We are already working with Takeda on solving the PTH issue, the manufacturing issue.

So, this will not yield change and if indeed, we can put in place with patients, named programs quickly. This could generate some interesting revenues in the months ahead. So all in all, I would say that, for 2013, I am not saying that the expenses will be nil. All I am saying is, it will not materially change our guidance if you will that we defined earlier.

So, stay tuned. Needless to say that 2014 and further we are building an international organization. As we have done it before, this is our MO. We are a company that is very prudent. We do things in a very diligent, strategic and thoughtful way and most of our activities have been gaited in our build up and will continue to be gaited in our international expansion.

Ed Arce – MLV & Company

Okay, great and just one last question. Given that as you said that, NPS is really best suited to market, Gattex and Natpara in the EU, specifically with, I guess Gattex and do you have any changes to your prior peak sales estimates?

Francois Nader

In the US we have guided that we will exceed the $350 million and frankly we know that we will. But it’s very difficult to pinpoint a specific number before we have, I would say, little bit of time under our belt regarding the launch. We are in week six I believe today. And it’s early days, as Eric said, these are early days.

But we are very pleased with where we are today having patients already on drug was a positive surprise given the traditionally reimbursement could take anywhere between nine to twelve weeks. The feedback that we receive from the payers has been so far very positive.

We did not have any pushback and the concern that some had related to the out-of-pocket for patients, actually appear to be not funded, because the out-of-pocket so far has been $10 per patient per month, which is frankly negligible given the benefit of Gattex. So the data points are extremely encouraging.

Another point I’d like to make just to clarify a comment that you made earlier, one thing that I’m particularly excited about regarding this transaction is the fact that it is, we are regaining the worldwide rights. And I am thinking of countries with true unmet medical needs regarding hypoparathyroidism, like Japan for example or other countries that are emerging.

So even though, Revestive now is approved in Europe and Europe will be our, I would say, first priority because the product is approved. We will be putting together very quickly a regulatory strategy to file both PTH and Revestive in the key countries outside Europe, because these are emerging markets, but very interesting markets and based on our assessment, reimbursements are very interesting out there.

So, we will expand beyond Europe hopefully very soon and this is another activity that will not be very expensive in the sense that it will take the time it takes for these products to be approved and filing is not terribly expensive. It is building the foundation for the future and to have these products, two products become really worldwide products.

Ed Arce – MLV & Company

Okay, thank you Francois and congratulations on the deal.

Francois Nader

Thank you very much.

Operator

Thank you and now I would like to turn the call back over to Dr. Nader for closing remarks. Over to you.

Francois Nader

Thank you, Gary and thank you all for your questions. We are indeed very excited by today’s news and we look forward providing you with additional details on our strategy to become one of world’s premier orphan drug companies. With that, I appreciate your time and wish you a great day.

Operator

Thank you very much ladies and gentlemen. That now concludes your conference call for today. You may now disconnect. Thank you.

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